High-Definition Manometry: A Novel Diagnostic Tool

DESCRIPTION (provided by applicant): Gastrointestinal motility disorders remain significant both in terms of prevalence and morbidity (e.g., suffering, functional impairment, and health care resource use). Intraluminal manometry is an important diagnostic tool, but technological limitations of current devices having relatively few pressure sensing sites have restricted its clinical use. These limitations are strongly apparent in anorectal manometry where the complex muscular structures are closely spaced and asymmetric structural defects may exist. The novel application of tactile technology to manometric measurement will yield high-definition pressure images of this region. High-definition manometry likely will improve diagnosis and treatment of millions of people with anorectal motor dysfunction (e.g., anal incontinence, constipation). The techniques when applied to other organ regions also may benefit patients with other pelvic floor disorders, gastroesophageal reflux disease, and motility disorders in upper gut sites. In this Phase I effort we will build a functional prototype high-definition motility visualization system (HD-MVS) with as many as one hundred fold more pressure sensors than are used in current anorectal manometry systems. The data will be displayed on a 3-D model that will ultimately project the radial and circumferential distributions of contractile pressure within the region. We will optimize the probe form factor for anorectal study and perform technology advancements to demonstrate that the sensor is capable of meeting key performance requirements. The HD-MVS will yield unique benefits for physicians, clinical staff, and patients. High-definition coverage of the entire organ surface promises simplified and shortened clinical procedures with greater consistency in study data site-to-site. The ability to isolate and characterize physiological abnormalities should be dramatically improved. This technology has the potential to significantly expand the clinical utility of manometric assessment in disease management.